Change to Come for Generic Drug Laws

Posted By
Pintas & Mullins Law Firm

Today, eight in ten prescriptions are for generic drugs rather than brand
names. Just thirty years ago, that number was three in ten. Generic drugs
have been the topic of much debate lately, as courts and agencies throughout
the country try to decide whether they should be able to update their
own drug labels apart from the labels of their brand-name counterparts.
Dangerous drug lawyers look further into this issue and how this decision will affect patients.

This issue was brought to the Supreme Court in 2011, in
PLIVA v. Mensing. The argument in this case, made my Mensing, was that generic drug manufacturers
should have the same opportunity and requirement to change drug labels
as their brand-name equivalents. So, if a generic company like PLIVA knew
that one of its drugs caused a serious side effect, Mensing argued, it
should be required to notify the FDA and lobby for a label change.

PLIVA argued that this kind of federal regulation would directly conflict
with state laws, opening the companies up to drug injury. Currently, all
generic drug makers are required to have the same labels as their generic
counterparts (so the branded Abilify will have the exact same ingredients
and labels as the generic form, aripiprazole).

In a 5-4 decision, the Supreme Court ruled that states could not hold generic
drug companies liable for failing to include additional safety information,
since it was not required by federal law. This was partially based on
a 30-year old law known as the Hatch-Waxman Act, which streamlined the
approval process for generic drugs.

The FDA may change the federal regulations relating to generic drugs soon,
however. On or before
September 30, 2015, the FDA will propose a final rule on labeling changes for generic drugs.
This new rule will likely reverse the 2011 PLIVA v. Mensing decision,
and trigger immediate legal fights over the liability of generic drugs.

This is important for many reasons. As stated, generic drugs are currently
protected from injury lawsuits filed by patients who were injured by their
drugs. If they are allowed to update their labels, it will open them up
to liability for failing to warn about any possible side effects patients
may suffer while taking their drugs. Since the vast majority of prescriptions
are for generics, the potential for drug injury claims is enormous.

Most patients do not realize that if they are seriously injured by a generic
drug, they would not be able to sue the company for failing to warn about
its risks. Yet these patients are often forced to take generic drugs because
the brand-names are utterly unaffordable. It’s a no-win situation,
and the FDA is headed in the right direction to help the sick and vulnerable.

Concerns on Capitol Hill

There are other repercussions to such a rule change beyond the scope of
plaintiffs’ rights.
A recent article in
Slate goes into more depth on the Hatch-Waxman Act, describing a different conversation
in Washington over generic drugs.

In recent years, generic drug prices have increased dramatically –
critical drugs, like antibiotics, that used to cost pennies now cost hundreds
of dollars per bottle. The current state of drug pricing in the U.S. is
based off the belief that the monopolies of Big Pharma, which manufacture
brand names, can be offset by so-called little pharma, which make generics.

Thus, patients are given two options for the drugs they need: the brand-name,
which is monopolized by one company, or, when the patent runs out, the
generic, which is supposed to be made by multiple companies at more affordable
prices. The problem with this is that “little pharma” is a
competitive industry just like Big Pharma. Generic companies often ditch
smaller, less profitable drugs (like antibiotics) to sell newer, more
profitable drugs.

This leaves just one generic company to sell the smaller drugs, which
means it has a monopoly on that drug, and can price it however it wants,
just like brand-names. The
Slate author concludes that the American free market drug system has failed,
as price surges and supply shortages becoming more and more prevalent.

Our team of
dangerous drug lawyers has been working on these cases for 30 years, and has seen first-hand
how devastating injuries can be. If you or someone you love suffered a
serious side effect from a pharmaceutical or medical device, contact our
firm immediately. Our legal consultations are always free of charge, and
available to potential clients nationwide.

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